Qilu Pharmaceutical's Global First PD-1/CTLA-4 Bispecific Combination Antibody Iparomlimab and Tuvonralimab Injection (Qizean®) Receives Conditional Approval in China for Recurrent or Metastatic Cervical Cancer

On September 30, the official website of the National Medical Products Administration (NMPA) showed that it hadConditional Approval Granted to Qilu Pharmaceutical Co., Ltd.'s Application for the Marketing of Aipalolituo Weirili Monoclonal Antibody Injection (QL1706, Trade Name: Qibean) for the Treatment of Recurrent or Metastatic Cervical Cancer Patients Who Have Failed Prior Platinum-Based Chemotherapy.

Iparomlimab-Tuvonralimab is a Class 1 new drug developed by Qilu Pharmaceutical based on the MabPair technology platform. It consists of Iparomlimab, an IgG4 antibody targeting PD-1, and Tuvonralimab, an IgG1 antibody targeting CTLA-4, combined in a fixed ratio. It has a synergistic mechanism of action that simultaneously blocks PD-1 and CTLA-4. The CTLA-4 antibody component has been modified to reduce its half-life and toxicity. Iparomlimab-Tuvonralimab can maintain normal PD-1 antibody exposure in the body while reducing CTLA-4 antibody exposure, making it a promising dual immunotherapy with potentially lower toxicity and better tolerability.

Source: Public information from Qilu Pharmaceutical

DUBHE-C-206 Study Results Show that Aipalolituo Vorilizumab Demonstrates Promising Efficacy and Manageable Safety in Patients with Recurrent/Metastatic Cervical Cancer After First-Line Chemotherapy Failure. This single-arm, multi-center, open-label Phase II clinical study enrolled 148 patients with cervical cancer whose first-line platinum-based chemotherapy (± bevacizumab) had failed and who had not previously received immunotherapy. Among them, 59 patients (39.9%) had a history of bevacizumab treatment, and 55 patients (37.2%) had previously received ≥2 lines of therapy.

The results showed that the study met the pre-set endpoint. After a median follow-up of 11.0 (0.7~15.5) months, the ORR assessed by the Independent Review Committee (IRC) was 33.8%, the disease control rate (DCR) was 64.9%, the median progression-free survival (mPFS) reached 5.4 months, and the median overall survival (mOS) was not reached. Stratification by PD-L1 revealed that the ORR in patients with high PD-L1 expression (CPS≥1) and low PD-L1 expression (CPS<1) was 33.8% and 25.6%, respectively. In terms of safety, QL1706 demonstrated good overall tolerability in previously treated recurrent/metastatic cervical cancer, with only a small proportion (2.0%) of patients discontinuing treatment due to treatment-related adverse events (TRAE).

The PharmaCube database shows that the Phase II clinical study of Aipalolitovirali monoclonal antibody as a first-line treatment for cervical cancer has also achieved positive results. Qilu Pharmaceutical has also launched multiple clinical studies of Aipalolitovirali monoclonal antibody in other cancer types, including liver cancer, nasopharyngeal cancer, and non-small cell lung cancer.